pressure activated valves for catheters with improved tolerance of high pressure and high flow conditions are described. Embodiments of the valve comprise a flexible membrane with one or more linear slits therethrough, and means for applying tension to the flexible membrane in-line with the linear slits. The application of tension may optionally be facilitated by structural features of both the flexible membrane and the valve housing.
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1. A pressure activated valve, comprising:
a flexible membrane having at least one linear slit therethrough, the membrane being under tension along a longitudinal axis defined by the at least one linear slit;
wherein the longitudinal axis comprises two or more portions with a thickness greater than the remaining flexible membrane.
2. A pressure activated valve, comprising:
a flexible membrane having at least one linear slit therethrough, the membrane being under tension along a longitudinal axis defined by the at least one linear slit;
wherein the flexible membrane comprises one or more tabs that extend along the longitudinal axis, such that a length of the longitudinal axis is greater than a length of a bisecting latitudinal axis; and
wherein a valve housing and the flexible membrane are configured to apply a tensioning force along the first axis and extending away from the second axis.
10. A pressure activated valve comprising:
a valve housing defining a lumen, the valve housing comprising:
a first valve housing portion having a first mating surface; and
a second valve housing portion having a second mating surface in contact with the first mating surface; and
a flexible membrane disposed within the lumen, the flexible membrane having a first slit therethrough;
wherein the first slit lies along a first axis of the flexible membrane, said first axis having two or more portions with a thickness greater than a thickness along a second axis of the flexible membrane, the second axis perpendicularly bisecting the first axis; and
wherein the valve housing and the flexible membrane are configured to apply a tensioning force along the first axis and extending away from the second axis.
3. A pressure activated valve, comprising:
a valve housing defining a lumen, the valve housing comprising:
a first valve housing portion having a first mating surface; and
a second valve housing portion having a second mating surface in contact with the first mating surface; and
a flexible membrane disposed within the lumen, the flexible membrane having a first slit therethrough;
wherein the first slit lies along a first axis of the flexible membrane, the first axis perpendicularly bisecting a second axis;
wherein the flexible membrane comprises one or more tabs that extend along the first axis, such that a length of the first axis is greater than a length of the second axis; and
wherein the valve housing and the flexible membrane are configured to apply a tensioning force along the first axis and extending away from the second axis.
6. The pressure activated valve of
7. The pressure activated valve of
8. The pressure activated valve of
11. The pressure activated valve of
12. The pressure activated valve of
13. The pressure activated valve of
14. The pressure activated valve of
15. The pressure activated valve of
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The present application incorporates by reference the entire disclosure of U.S. Pat. Nos. 5,843,044 and 5,984,902, both entitled “Outdwelling slit valve and variable control for controlling opening and closing the slit” and both naming H. Robert Moorehead as inventor. The present application also incorporates by reference the entire disclosure of: (i) U.S. Publication No. 2005/0171489, entitled “Pressure activated safety valve with anti-adherent coating” and naming Karla Weaver and Paul DiCarlo as inventors; (ii) U.S. Publication No. 2005/0171488, entitled “Pressure activated safety valve with high-flow slit” and naming Karla Weaver and Paul DiCarlo as inventors; (iii) U.S. Publication No. 2005/0171490, entitled “Stacked membrane for pressure actuated valve” and naming Karla Weaver and Paul DiCarlo as inventors; (iv) U.S. Publication No. 2009/0177187, entitled “Pressure activated valve with angled slit” and naming Karla Weaver Quigley, Steven Grantz, Richard Pok, Anthony Hien and Kimberly Un as inventors; and (v) U.S. Publication No. 2005/0027261, entitled “Pressure actuated valve with improved slit configuration” and naming Karla Weaver and Jim Culhane as inventors.
The present invention relates to valves for catheters such as the PASV® valve technology commercialized by Navilyst Medical, Inc.
Many medical procedures, such as chemotherapy, intraveneous antibiotic therapy, and parenteral nutrition administration, require repeated and prolonged access to a patient's vascular system. Because it may be impractical or even dangerous to insert and remove a needle or catheter each time vascular access is needed in these applications, treatments requiring repeated vascular access over long periods of time utilize implantable vascular access catheter assemblies.
A vascular access catheter assembly may be implanted semi-permanently, with a distal end of the assembly remaining within the patient in contact with the vascular system while a proximal end remains external to the vasculature, for example in the form of a subcutaneously implanted port or an outdwelling proximal catheter access point. The proximal end is sealed when not in use to prevent blood loss and infections.
A common method of sealing an implanted catheter after use is to shut the catheter with a simple clamp. This method is often unsatisfactory because the repeated application of the clamp may weaken the walls of the catheter due to the stress placed on the walls at a single point. In addition, the pinched area of the catheter may not be completely sealed. Alternatively, pressure activated valves have been used at the proximal ends of catheters. Pressure activated valves seal rapidly and reliably without any operator input, do not affect catheter patency even after many opening and sealing cycles, and can tolerate the relatively low pressures and flow rates required for many applications for long periods of time. However, certain applications, such as infusion of contrast media for contrast-enhanced CT scanning require very high pressures and flow rates which may damage currently available pressure activated valves. It would be desirable to provide a pressure activated valve for a catheter with improved tolerance of high pressures and high flow rates.
In one aspect, the present invention addresses the need described above by providing a pressure activated valve with improved suitability for high pressure injection. In some embodiments, the present invention comprises a valve apparatus for medical applications including a valve housing that defines a lumen and has first and second valve housing portions, which valve housing portions have first and second mating surfaces that are in contact with one-another, and a flexible membrane with one or more linear slits. The mating surfaces define a space that is in-line with an axis defined by a slit through the membrane and is sized to accommodate a portion of the membrane.
In other embodiments, the present invention comprises a valve apparatus comprising a flexible membrane with one or more linear slits and one or more tabs positioned in-line with at least one of the linear slits.
In still other embodiments, the present invention comprises a valve apparatus comprising a flexible membrane with a central portion with a first thickness, which comprises one or more linear slits, and an edge portion with a second thickness, which edge portion is in-line with at least one of the linear slits of the central portion, where the second thickness is greater than the first thickness.
In the drawings, like reference characters generally refer to the same parts throughout the different views. Drawings are not necessarily to scale, as emphasis is placed on illustration of the principles of the invention.
Throughout this specification, for purposes of illustrating the principles of the invention, reference is made to valves with substantially planar, flexible membranes having a single, linear slit as a flow control mechanism. However, it will be understood by those skilled in the art that the invention is compatible with a variety of slit arrangements, including membranes having a plurality of linear slits, and membranes having slits which extend through the thickness of the flexible membrane at an angle relative to the planes defined by the surfaces of the membrane, as described in United States Publication No. 2009/0177187.
The present invention provides pressure activated valves having improved tolerance of high-pressure injection conditions. The invention utilizes flexible membranes incorporating one or more linear slits as flow-control elements, and structural features which selectively apply tension to the membrane along axes defined by the linear slits. The tensioning force applied by these features helps the edges of the slits resist the pressures applied during high-pressure injections without deforming and helps bias the edges to return to their ordinary, closed positions without puckering or folding once the high pressure injection has stopped.
In certain embodiments, tension is selectively increased about an axis defined by a slit in a flexible membrane through the incorporation of one or more tabs into the membrane, which tab or tabs are positioned along the longitudinal axis defined by the slit as shown in
The tab or tabs 120 may be angular as in
In alternate embodiments, such as those shown in
In certain embodiments, tension along the axis of the linear slit is achieved, in part, by increasing the thickness of a portion or portions of the flexible membrane about an axis defined by a slit in the flexible membrane is increased relative to the rest of the membrane. For example, in the embodiment shown in
Compressive force is applied to the edge regions 130 in different ways. In certain embodiments, as illustrated in
In certain embodiments, tension is selectively applied to the flexible membrane about the axis defined by a linear slit by compressing or folding the edge of the membrane and providing an adjacent space into which the edge of the membrane can be displaced. By varying the degree of displacement, the tension on the membrane may be varied. In a preferred embodiment, as shown in
In certain embodiments such as those shown in
In embodiments as shown in
These embodiments have been described in an exemplary manner, and are not intended to limit the scope of the invention which is intended to cover all modifications and variations of this invention that come within the scope of the appended claims and their equivalents. The specification is, therefore, to be regarded in an illustrative rather than a restrictive sense.
Buiser, Marcia, Casiello, Damon, Karnafel, Paul E., Aubin, Charles R.
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